Senior Statistical Programmer

Role: Senior Statistical Programmer supporting biostatistics activities in clinical development for a rare neuroendocrine disease biopharma. Objectives include delivering analysis datasets, tables, listings, figures, and supporting regulatory submissions. Responsibilities encompass leading or supporting programming for clinical studies, developing and maintaining SDTM/ADaM specifications, ensuring regulatory compliance, and collaborating with cross-functional teams such as Biostatistics, Data Management, Clinical Development, and Regulatory Affairs. The role may also include mentorship, process improvement, and vendor oversight. Qualifications include an MS in Statistics, Biostatistics, or related fields, with 3+ years of SAS programming experience in biotech/pharma/CRO settings, and expertise in CDISC standards and trial analysis. Preferred skills involve experience with R or modern tools, vendor oversight, and supporting study-level and integrated analyses (e.g., ISS/ISE). The position is based in Boston, MA, operating under a hybrid-work model, with potential travel. The role involves work within the regulatory stage, supporting INDs, regulatory submissions, and clinical trial reporting in a GxP environment.